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Tag Archives: FDA

The Environmental Protection Agency awarded Michigan $100 million to help replace Flint’s badly eroded and damaged water infrastructure.

The funding was provided by the Water Infrastructure Improvements for the Nation Act of 2016 and enables the beleaguered city to replace its decaying lead water pipes. Michigan is providing the required 20 percent match of $20 million.

The fix is part of the Trump administration’s goal of updating the country’s water infrastructure, EPA administrator Scott Pruitt said Friday in a press statement.

“The people of Flint and all Americans deserve a more responsive federal government,” he said. “EPA will especially focus on helping Michigan improve Flint’s water infrastructure as part of our larger goal of improving America’s water infrastructure.”

Michigan Democrats and Republicans praised the EPA’s decision to infuse money into the dilapidated city’s broken water supply.

It said ‘Chickweed Salve’ up top, then on down said ‘Cures Cancer,’ she explained. “Which for some people it did, but he can’t say that. So he changed it to say ‘Healing Chickweed,’ but they said no you can’t say healing. So now it just says ‘Original Chickweed.'”

“I mean do you go to jail because you’ve messed up a label on a product?” asked Moody. “I thought you went to jail because you did something bad. I mean he mislabeled something? I doubt he knew any better.”

Girod has been making the product for over 20 years and sold it in small convenience stores.

The Lexington Herald Leader reports, “The grand jury indicted Samuel A. Girod on a dozen charges, including conspiracy, distributing misbranded drugs and threatening a witness to try to keep business documents away from the grand jury. The witness-tampering charge, the most serious, carries a maximum penalty of 20 years in prison.”

Dara Corrigan, associate commissioner for regulatory affairs for the U.S. Food and Drug Administration, and David M. Ketchmark, Acting U.S. Attorney for the Western District of Missouri, announced today that U.S. Marshals have seized drugs being held by Notions-n-Things Distribution of Bogard, Mo. Yesterday’s seizure follows a civil forfeiture complaint that was filed in the U.S. District Court in Kansas City, Mo. Federal marshals seized more than 1,600 containers of products that allegedly violate FDA approval and labeling requirements.

U.S. District Judge Gary A. Fenner of the U.S. District Court for the Western District of Missouri signed the seizure order on Tuesday, March 27, 2012. The seizure covered three products: Chickweed Healing Salve, allegedly marketed as a skin cancer treatment containing comfrey; To-Mor-Gone, which allegedly claims to cure cancer and other diseases; and R.E.P., which allegedly claims to cure stress headaches and sinus infections, but contains no ingredient information on its label.

FDA requested the seizure, the complaint says, because the products claim to treat or cure diseases but have not received FDA approval, and are not exempt from such approval requirements. Moreover, the complaint says, the seized products contain ingredients that could cause toxic or allergic reactions in consumers sensitive to these ingredients. According to the federal complaint, Chickweed Healing Salve contains comfrey, which may increase the risk of systemic toxicity, and To-More-Gone contains bloodroot, a caustic, corrosive substance that produces a thick scar that can mask tumor recurrence. In addition, the seized products are “misbranded” under the Federal Food, Drug and Cosmetic Act.

Dara A. Corrigan, associate commissioner for regulatory affairs, said, ““Two important protections for the public are that a firm may not sell new drugs unless they have been tested and approved by FDA and a firm may not make false or unsubstantiated claims about drugs they sell. When a firm disregards these protections, it not only violates the law but also creates a risk for consumers, who may rely on a bogus product and forego effective and proven treatment. FDA must and will take aggressive enforcement action.”

No one was injured or harmed by Girod’s product. In fact, many people testify that they were helped by it. Fine. I ask the FDA how many drugs they approve that have tremendous side effects, including death, but they are just fine approving it, as long as it’s on the label. How does that actually protect anyone?

So does this mean there is going to be an FDA raid on Etsy and metaphysical shops?! How about these companies that sell oils and extracts that have books telling you how to cure everything from acne to cancer with the use of oils? I can understand requiring him to remove unproven claims from the label, but my God! This is insane!

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Normally when we discuss the intersection of the FDA, government regulations and tobacco we’re talking about cigarettes. (Or vaping in more recent days.) But this week Uncle Sam is getting into full retro mode and going after cigar manufacturers. The most recent spate of moves in the Food and Drug Administration aimed at saving the nation from itself is based on a bit of legislation passed more than six years ago known as the Family Smoking Prevention and Tobacco Control Act. This act was supposed to be targeted towards the prevention of tobacco advertising geared toward minors and enforcement of labeling requirements and a few other details. It also included a rather ominous provision described as the authority “to take further action in the future to protect public health.”

Apparently “the future” has arrived and some of those further actions will be geared toward traditional manufacturers of cigars rather than the cigarette market which is the major concern when it comes to children and families. At The Resurgent, Philip Swicegood explains how this is going to shake out.

That legislation—the Family Smoking Prevention and Tobacco Control Act—allows the FDA to regulate the manufacture, distribution, and marketing of tobacco products. FDA is supposed to use this power to prevent minors from getting access to tobacco products, which kids surely do—albeit not really cigars, which is what FDA is targeting. Setting aside that cigars have a totally different appeal to cigarettes, and there’s not a ton of crossover between cigar and cigarette-smokers, as anyone who’s ever been to a cigar shop knows, it’s basically impossible for an underage person to buy hand-rolled cigars, anyway, as a matter of logistics and shop layouts.

But the FDA is pursuing its heavy-handed regulation of cigars anyway. What precisely are they doing, and what are the implications? According to cigar blog Half Wheel, “cigar prices are going up” and “a lot of cigars—not just limited editions—will go away.”

Cigars reach an entirely different market for the most part and aren’t really the go-to choice for people just looking for a nicotine fix. The ones which are even marginally palatable cost more than cigarettes and you need more time (and space) to enjoy one. The packaging tends to be entirely different also. Enforcing these labeling rules is going to put a major hitch in the manufacturing process and may well drive some smaller producers out of an already difficult market.

Basically, the crappy cigars at the gas station that people buy to dump the tobacco out of and replace with weed are going to be just fine. But if you enjoy a good cigar, your manufacturers may be headed for tough times. That’s basically how it usually works.

Earlier this year, the Food and Drug Administration (FDA) finalized a rule that extended the agency’s authority to regulate electronic cigarettes and related vapor products as tobacco products. However, these products do not actually contain tobacco.

In so doing, FDA started the clock ticking toward August 8, 2018, the date on which e-cigarettes, e-liquids and other related newly deemed tobacco products that do not have FDA approval to remain on the market can no longer be legally sold.

E-cigarette products can only stay on the market after this ‘predicate date’ if a manufacturer undertakes a package of research that is required by FDA to consider granting approval for a product to stay on the market.

Experts have estimated that undertaking this research package to a good standard could cost a manufacturer at least $3 million per product it wishes to keep on the market. In other words, if an e-liquid manufacturer wants to sell four different flavors of e-liquid, the manufacturer would have to pay in the region of $12 million to conduct or commission research on those four products, none of which guarantees FDA will grant approval for any of the four liquids.

Some of the major companies will be able to shoulder this financial burden, but it is highly likely that the vast majority of small and independent manufacturers will not, and so, will be put out of business.

What, then, will people who currently use e-cigarettes do if, on August 8th 2018, their preferred products are no longer legally available to buy. My research team at the Centre for Substance Use Research (CSUR) recently asked this question to more than 9,000 US-based e-cigarette users, and the results should give FDA cause for alarm.

First, 8,451 current e-cigarette users who were also former cigarette smokers were asked what they would likely do if, as a consequence of the Deeming Rule, the e-cigarette products they use right now were taken off the market. Approximately 73 percent of the vaping former smokers indicated they would ‘bulk buy’/stock up on their preferred products before the rule was implemented.

Nearly 70 percent indicated they would start to source their e-cigarettes and e-liquids from a non-licensed vendor, and so fuel a black market trade in e-cigarettes. In addition, 66 percent of vaping former smokers said they would likely start to import e-cigarettes from overseas, and 65percent said they would start making and mixing their own e-liquids at home — in other words, they would become not merely a consumer, but also a manufacturer of e-cigarette products.

It is very likely that each of these intended responses to FDA’s regulations would pose much greater risks to the health of consumers than are being posed by the e-cigarette products that are currently being sold in stores across the US. These unintended consequences — in particular, driving consumers to an underground ‘black market’ trade in e-cigarette products of dubious manufacturing standards and unknowable toxicity — would both undermine FDA’s ability to assess the population health impact of its own rule, and undermine the FDA’s stated mission of improving and protecting the health of Americans.

There’s also a lot of folks who would return to traditional cigarettes.

But we all know that the government doesn’t seem to mind starting the roll of the black market on items they want to ban “for our own good.”

I vape. Personally, I would probably bulk buy and start mixing my own.

What a lot of people are missing in this entire thing is the large amount of big tobacco companies that have actually purchased companies like Blu e-cigarettes. The big tobacco companies are the ones that will be able to foot the bill for the FDA approval and meet their ridiculous demands. Big tobacco is behind all of this, because without the smaller manufacturers, people who vape – they assume – will be forced to buy and use the garbage they produce. And believe me… it’s all garbage. The taste is terrible and, frankly, most of them have a minimum nicotine content that is much higher than what smaller manufacturers are willing to go. I get 30-100 ml bottles that contain 3 mg of nicotine. Smaller guys also use propylene glycol, vegetable glycerine, and food grade flavoring (that’s literally it). Who the hell knows what’s in the juice from big tobacco… probably the same junk in the cigarettes.

Amazing. So, as with everything else, this isn’t for the good of the people. It’s for the good of big tobacco. Period.

Frosted Flakes are healthy, but salmon, almonds and avocados aren’t? You read correctly—at least, according to the FDA. The agency hasn’t updated its guidelines for what makes foods like these “healthy” since 1994, back when low-fat cookies that tasted like cardboard were all the rage. But that may be changing, the Wall Street Journal reports.

The agency said in a statement this week: “We believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.'” Part of what prompted this is a petition from KIND LLC, the popular granola bar maker. Last year, the company received a letter from the FDA demanding that it remove the word “healthy” from its packaging, because it currently doesn’t fit the standing definition (though Pop-Tarts are fine). KIND challenged the agency and last month was finally told it could use the term “healthy and tasty,” but not on its nutrition label.

Senate lawmakers voted overwhelmingly Wednesday to confirm Robert Califf, a longtime cardiologist and academic researcher, as the next commissioner of the Food and Drug Administration.

The final tally was 89 to 4.

“Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market,” Health and Human Services Secretary Sylvia M. Burwell said in a statement.

Califf, who joined the FDA a year ago after decades as a researcher and administrator at Duke University, was nominated by President Obama to run the agency last September. But in the months that followed, his nomination faced opposition from a handful of senators, over everything from the nation’s prescription painkiller epidemic to genetically engineered salmon.

Democratic presidential candidate Sen. Bernie Sanders (Vt.) has staunchly opposed Califf’s confirmation, insisting that his professional history — a 2014 financial disclosure showed his salary at Duke was underwritten partly by funding from large drugmakers such as Eli Lilly and Merck, and drug companies helped fund research studies he oversaw — would prevent him from aggressively regulating the industry and looking out for ordinary patients.

Califf said in his confirmation hearing last fall that the drug companies routinely funds such studies and that working the industry is a modern necessity, but that Duke’s contracts protected the independence of investigators to publish research outcomes, whatever the results. He said he had never advocated for lowering standards around the safety or efficacy of drugs and wouldn’t as head of the FDA. He repeated that vow in an interview Wednesday.

“I think my record shows that I’m for medical products that work and are effective. When they’re not, I’ve been outspoken,” Califf said shortly after his confirmation. “I think the best testament is that I went through an amazingly rigorous committee, hundreds of pages of written documentation, and then a full Senate review, and came out pretty well.

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The Food and Drug Administration just approved genetically modified salmon patented by a company called AquaBounty Technologies, which means it will start showing up in the market in two years or so. The New York Timesreports:

“The F.D.A. has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the AquAdvantage salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” Bernadette Dunham, director of the agency’s Center for Veterinary Medicine, said in a statement.

The FDA’s Center for Veterinary Medicine? That’s right, because:

The F.D.A. regulates genetically engineered animals as veterinary drugs, using the argument that the gene inserted into the animal meets the definition of a drug. Critics have branded this an inadequate solution intended to squeeze a new technology into an old regulatory framework. They say the F.D.A. is not as qualified as other government agencies to do environmental assessments. The White House is now reviewing the entire framework for regulating genetically engineered products.

But not before approving genetically modified animals for human consumption. The Times quotes the sensible statement of Rep. Don Young, describing this as a “harebrained decision” that “goes to show that our federal agencies are incapable of using common sense.” It then adds:

But some scientists have dismissed these concerns. William Muir, a professor of animal sciences at Purdue University, said the fish posed no risk to the environment. “In contrast, the current practice of using wild caught salmon as a food source is not sustainable; our oceans are overfished,” he said in a statement. “This development provides a safe and sustainable alternative.”